Dec 05, 2019: The U.S. Food and Drug Administration approved three applications for the first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients.
MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body more frequently in women than men.
Fingolimod risks include slowing of the heart rate, especially after the first dose, may also increase the risk of serious infections. Patient taking this drug are reported with a rare brain infection that usually leads to death or severe disability, called progressive multifocal leukoencephalopathy (PML) has been reported. https://fda.einnews.com/pr_news/504090689/fda-approves-first-generics-of-gilenya